Cleared Traditional

K993843 - MDI RF TEST

K993843 is an FDA 510(k) clearance for MDI RF TEST, manufactured by Micro Detect, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K993843 · Micro Detect, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
60d
Days
Class 2
Risk

K993843 is an FDA 510(k) clearance for the MDI RF TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Detect, Inc. devices

FDA 510(k) Submission Details - K993843

510(k) Number K993843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date January 11, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 105d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHR System, Test, Rheumatoid Factor

All 109
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K993843.
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · Roche Diagnostics Corp. · Apr 2000
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557 · Cogent Diagnotics , Ltd. · Mar 2000
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · Cogent Diagnotics , Ltd. · Feb 2000
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · Cogent Diagnotics , Ltd. · Dec 1999
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
K991467 · Kamiya Biomedical Co. · Jun 1999
K-ASSAY RHEUMATOID FACTOR
K991409 · Kamiya Biomedical Co. · Jun 1999